17 alfa-OH Progesterona Test System – ELISA

17-Hydroxyprogesterone (17-OHP) - newborn screening · class III · Until 12/05/2035

Registration no.
80048490105
Process no.
25351434132202468
Status
Until 12/05/2035
Device type
17-Hydroxyprogesterone (17-OHP) - newborn screening (17-HIDROXIPROGESTERONA (17-OHP) - TRIAGEM NEONATAL)
Risk class
III
Registration holder
USA DIAGNOSTICA LTDA CNPJ 02.330.159/0001-08 · 106 registrations
Manufacturer
MONOBIND, INC · United States
Published
12/05/2025
Valid until
12/05/2035
Last updated by ANVISA
2026-10-12
Official record
View on ANVISA ↗

Other 17-hydroxyprogesterone (17-ohp) - newborn screening registrations (5 in total, see all)

ProductClass HolderPublishedStatus
Neonatal 17-OH-Progesterone FEIA
81541770004
III SUPER DIAGNOSTICA PRODS HOSP LTDA EPP 11/08/2025 Until 11/08/2035
IMUNOSCREEN NEO 17-OHP DBS
80047580220
III MBIOLOG DIAGNÓSTICOS LTDA 14/02/2024 Until 14/02/2034
GSP Neonatal 17 a-OH-progesterone kit
10298910105
III REVVITY DO BRASIL LTDA 23/06/2010 Until 23/06/2035
KIT DELFIA AUTODELFIA 17 ALFA-HIDROXIPROGESTERONA NEONATAL
10298910015
III REVVITY DO BRASIL LTDA 23/09/1996 Until 23/09/2036